Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000753853
Ethics application status
Approved
Date submitted
13/07/2012
Date registered
16/07/2012
Date last updated
27/06/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of potassium supplementation on blood vessel function
Scientific title
Acute effect of potassium supplementation on endothelial function in healthy populations
Secondary ID [1] 280845 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiovascular disease 286912 0
Condition category
Condition code
Diet and Nutrition 287237 287237 0 0
Other diet and nutrition disorders
Cardiovascular 287240 287240 0 0
Coronary heart disease
Cardiovascular 287246 287246 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Potassium supplemented soup meal (36mmol potassium) to be consumed within 15minutes versus control with 7day washout between visits
Intervention code [1] 285266 0
Treatment: Other
Intervention code [2] 285278 0
Prevention
Comparator / control treatment
Regular potassium soup meal (6mmol potassium) to be consumed within 15minutes
Control group
Active

Outcomes
Primary outcome [1] 287520 0
Brachial artery flow mediated dilatation (FMD) - percentage of dilatation
Timepoint [1] 287520 0
measured at 30min intervals for 2hours postprandially
Secondary outcome [1] 298313 0
Nil
Timepoint [1] 298313 0
Nil

Eligibility
Key inclusion criteria
BMI greather than 18kg/m2 and less than 27kg/m2
SBP <90mmHg DBP<130mmHg
weight stable for 6months
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Use of antihypertensive medication, systemic steroids, folate supplementation or non-steroidal antiinflammatory
drugs.
Metabolic disease such as liver or kidney disease.
Treated hypertension.
Previous clinical cardiovascular disease.
Unable to comprehend protocol.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The study will be advertised publicly. Participants will be enrolled and randomised to treatement order after screening. Treatment concealment is by coded containers that are administed to participants by a person independent to the study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The participants are assigned treatment order using a numbered random-allocation sequence generated by
using a computer program (CLINSTAT software) by a person independent to the study.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
30/07/2012
Actual
8/08/2012
Date of last participant enrolment
Anticipated
Actual
16/11/2012
Date of last data collection
Anticipated
Actual
7/12/2012
Sample size
Target
32
Accrual to date
Final
32
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 285629 0
University
Name [1] 285629 0
University of South Australia
Country [1] 285629 0
Australia
Primary sponsor type
University
Name
University of South Australia
Address
City East Campus
University of South Australia
GPO Box 2471
Adelaide
SA 5000
Country
Australia
Secondary sponsor category [1] 284463 0
None
Name [1] 284463 0
Address [1] 284463 0
Country [1] 284463 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287626 0
University of South Australia Human Research Ethics Committee
Ethics committee address [1] 287626 0
Ethics committee country [1] 287626 0
Australia
Date submitted for ethics approval [1] 287626 0
Approval date [1] 287626 0
11/07/2012
Ethics approval number [1] 287626 0
0000028282

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34435 0
A/Prof Associate Professor Jennifer Keogh
Address 34435 0
University of South Australia City East Campus North Terrace Adelaide SA 5000
Country 34435 0
Australia
Phone 34435 0
+61 8 8302 2579
Fax 34435 0
Email 34435 0
jennifer.keogh@unisa.edu.au
Contact person for public queries
Name 17682 0
Associate Professor Jennifer Keogh
Address 17682 0
University of South Australia
City East Campus
North Terrace
Adelaide SA 5000
Country 17682 0
Australia
Phone 17682 0
+61 8 8302 2579
Fax 17682 0
Email 17682 0
jennifer.keogh@unisa.edu.au
Contact person for scientific queries
Name 8610 0
Associate Professor Jennifer Keogh
Address 8610 0
University of South Australia
City East Campus
North Terrace
Adelaide SA 5000
Country 8610 0
Australia
Phone 8610 0
+61 8 8302 2579
Fax 8610 0
Email 8610 0
jennifer.keogh@unisa.edu.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.